Cel Sci Corporation New (CVM) News

When’s the R/S or another offering???As regards another offering - I'm guessing before the end of the calendar year, unless they get somebody with deep pockets backing the confirmatory trial. They have to get operating capital somewhere.

Another R/S? I don't think that's a big concern for quite some time yet. They have quite a bit of time to get the share prices back over $1 before market listing problems creep into the area of concern, at least 6 months as I understand it. And even then, they can request an extension before delisting.

When’s the R/S or another offering???

CVM new 52 week low

You really think anyone owns enough of this to sell off against gains?

Can't believe anyone still follows this loser. The drug failed miserably.

With many having nice gains this year in stocks, tax selling of losers like this should continue until year end. Since stocks do not generally get delisted until they are below a dollar for 6 months, a reverse split probably will not be needed to remain in compliance.
I plan on buying in January in anticipation of the finalization of the 212 person study before the end of the 1st quarter. Still a believer that this is an important weapon in treatment of head and neck cancer and perhaps other forms as well.

And we're back down under $1 again. Not a surprise as there's just too much up in the air at the moment. Until we get the confirmatory trial actually underway, and until we know how it is that they plan to fund that work, the risk is a known unknown.

Another guy who just vanished in 2020. It's almost as if.....well, they were working together or something.

Man, you disappeared about the same time as the others! Why?

Weird. You also disappeared in 2020 after telling me how sure this would make a fortune. Did Covid take you all down or did you dump and run?
You assured me this company was weeks away.

Boy, if you're around and lurking, I'd love to hear your opinion now. You just disappeared with no warning 4 years ago. One day optimistic, the next day gone.
Not even a goodbye?

Yep. And things are not going to trend better until/unless CVM gets that trial started, or until/unless some sort of partnership gets announced.

Just too much uncertainty about the near future otherwise. They are either going to have to raise capital and dilute, or get a deep-pocket partner onboard and sign away some of the future profits. I just don't see anybody even sniffing about a buyout until that trial is rolling and at least the initial tumor shrinkage data look good.

CVM new 52 week low

Agreed about the signing on of Ergomed - they are already up to speed with the drug and the test protocols.

I wonder if they are going to demand payment up front? Or if they will agree to a piece of the later revenue as payment for their running this trial?

Why is anyone still interested in this stock? I posted years back they were going to toxic finance the stock down to nothing.
Isn't that apparent yet?

The announcement of the hiring of Ergomed to conduct the 212 patient clinical trial has the important tidbit that the trail is expected to be commenced during the 1st quarter 2025. This stock will be subject to tax loss selling this quarter but should be a good purchase in January 2025. It may break the $1 mark and again be subject to possible delisting.

The FDA is corrupt. Rockefeller took over all medicine and the institutions in the 1920's. He destroyed the natural healing and prevention. The sheep still love chemical pills with side effects and treating instead of natural curing without side effects. There is no $$$ in healthy people. Also TPTB do not want us living long. Kill two birds with one stone (pill).

71 cents lower today than where I sold.

You never know with FDA. They knew for 30 years that a tiny amount of folic acid taken daily by pregnant women would prevent all cleft palettes and split lips in babies, refused to okay it as part of vitamins or supplements until a doctor sued them.

With the latest result indicating an over 80% Survival rate after 5 years as opposed to under 50% without Multikine, it appears that approval is a foregone conclusion after the confirmatory study succeeds. Stock remains a strong buy.

Continued good news - but when will that confirmatory study finally get underway?

CEL-SCI’s Multikine® Increased 5-Year Survival Rate to 82.6% in Locally Advanced Resectable Head & Neck Cancer Patients Who Were Deemed to be in the Treatment Group for Surgery and Radiation

https://www.stocktitan.net/news/CVM/cel-sci-s-multikine-r-increased-5-year-survival-rate-to-82-6-in-9xbf37sch81c.html

CEL-SCI (NYSE American: CVM) reported new data from its Phase 3 study of Multikine® at the ESMO 2024 Congress. The data shows that Multikine increased the 5-year survival rate to 82.6% in locally advanced resectable head and neck cancer patients deemed low risk for recurrence, compared to 47.3% with standard care alone. The treatment also demonstrated a 73% reduction in overall risk of death (hazard ratio of 0.27).

These results are highly relevant to CEL-SCI's upcoming 212-patient confirmatory Registration Study, which has received FDA approval. The study will focus on patients with newly diagnosed locally advanced primary head and neck cancer with no lymph node involvement and low PD-L1 tumor expression. The data suggests that better diagnostic technology, such as PET scans, could further optimize patient selection and improve Multikine's efficacy.

Yes and what the PR says b4 markets open Monday…

Oh ye of little faith. It will be interesting to see what they say at the conference in Barcelona tomorrow.

Highest volume in over 1 month. Hmmm

Wake up little Susie. Wake up.

CVM to present new data for Multikine at the European Society for Medial Oncology 2024 Medical Oncology Congress Saturday 9/13/24 in Barcelona Spain.

All quiet on the Western front.

From Zack's :

CVM: Start Your Engines – FDA Green Lights Confirmatory Registration Study
08/28/2024
By John Vandermosten, CFA

NYSE:CVM

READ THE FULL CVM RESEARCH REPORT

CEL-SCI Corporation (NYSE:CVM) reported its fiscal third quarter on August 15, 2024 with the submission of its Form 10-Q with the SEC and a press release on the following day. Since our previous update for the fiscal second quarter, CEL-SCI has added several new individuals to its ranks, conducted a population analysis and presented data at IDDST for IT-MATTERS and raised additional capital to support the advance of Multikine towards the confirmatory registrational trial.

Financial Review

CEL-SCI recognized no revenues for its fiscal third quarter ending June 30, 2023 and incurred operating expenses totaling $6.7 million during the three-month period. This resulted in a net loss available to common shareholders of ($7.5) million, or ($0.14) per share.

For the quarter ending June 30, 2023 versus the same prior year period:

- Expenses for research and development fell 18% to $4.7 million from $5.7 million. Lower Phase III study, employee stock compensation and miscellaneous costs contributed to the decrease and were partially offset by increased spending to prepare for the confirmatory registration study;

- General and administrative expenses decreased 20% to $2.0 million from $2.5 million on lower consulting fees and employee stock compensation partially offset by other miscellaneous expenses;

- Other non-operating items were $14,000 compared to ($8,000) in the prior year;

- Net interest expense of ($0.2) million compared with ($0.2) million was related to lease liabilities and was relatively constant;

- Modification of warrants totaled ($659,000) compared to zero as several series of warrants received an extension of expiration dates;

- Net loss totaled ($7.5) million versus ($8.4) million or ($0.14) and ($0.19) per share, respectively.

As of June 30, 2024, cash and equivalents totaled $0.4 million. Cash burn for the three-month period amounted to approximately ($4.6) million, up from 3Q:23’s ($5.9) million. Following the end of the quarter, CEL-SCI closed on a gross $10.8 million common stock offering. CEL-SCI holds no debt on its balance sheet.

CEL-SCI Milestones

- Appointment of Mario Gobbo to Board of Directors – April 2024

- Dr. Giovanni Selvaggi joins CEL-SCI as clinical advisor – June 2024

- Presentation at the International Drug Discovery Science & Technology (IDDST) Congress – June 2024

- Neoadjuvant Immunotherapy for Head and Neck Cancer: Low Tumor PD-L1 Expression - IT-MATTERS – RCT

- Presented by Dr. Eyal Talor

- CEL-SCI appoints Robert Watson as Chairperson of the Board – July 2024

- Feedback from various regulatory agencies - 2024

- Submission of license application to various agencies – 2024+

- Preparation for Multikine confirmatory trial - 2024

Post-Reporting Period Capital Raise

CEL-SCI announced the closing of its $10.8 million offering on July 29th in a press release. The company sold 10,845,000 shares of stock and pre-funded warrants at $1.00 per share. ThinkEquity served as the placement agent for the transaction. A post transaction summary identified 3,715,000 shares of common stock and 7,130,000 pre-funded warrants were issued.

Population Analysis

In further review of the IT-MATTERS data, CEL-SCI has conducted a bias analysis that was detailed in a July 26th press release. The analysis was conducted to ensure data quality, improve study validity, inform the interpretation of the data and to guide the upcoming confirmatory registration study. The data on patients’ age, sex, race, tumor location and staging find that the active arm and control arm are similar. It finds that the results in the study are reliable, generate reasonable conclusions and minimize the risk of bias.



The bias analysis was conducted for the Phase III study population of 923 patients with newly diagnosed resectable, locally advanced primary head and neck cancer, as well as the subgroup of 114 patients who had no lymph node involvement and had low PD-L1 tumor expression (determined via biopsy). This is the same population which will be drawn from for CEL-SCI’s upcoming confirmatory registration study.



Summary

Since our previous update, CEL-SCI has reported its latest quarterly financial and operational results, conducted a population analysis on the IT-MATTERS subjects, presented data at IDDST and added new faces to its ranks. CEL-SCI continues the planning for its anticipated confirmatory registrational study and raised an additional $10.8 million in July to further this effort. We maintain our valuation of $7.00.

As for the timeline, if they are able to enroll 53 patients a month on average, they would reach the quota on September 8. I'm locked and loaded here.
They have not yet even started the trial. And given that the patient population (N0 and PDL1 negative) is way smaller than that of P3 the enrollment rate will be smaller. I would say 2026 as a reasonable but aggressive estimate for completion.

As far as fast track, that is irrelevant. I think what you mean is accelerated (conditional) approval. That would be an approval based on tumor reduction by time of surgery as a proxy for OS. Possible, but far from clear that it would be accepted. Waiting on OS wold be years.

It is amazing that investors don't realize that when CVM reveals that they have enrolled the 212 patients to do the confirmatory study, this stock will move higher. If the study shows good preliminary results, they may be fast tracked. Watch for volume surge in the near future. As for the timeline, if they are able to enroll 53 patients a month on average, they would reach the quota on September 8. I'm locked and loaded here.

CVM under $2

Obviously the key here will be the success of the upcoming confirmatory trial for those with head and neck cancer that has not spread to the lymph nodes. That group is more likely to survive this pernicious disease that had claimed the lives of loved ones all over the earth. God Bless them and pray that they succeed.

Patience is the buy word.

Multikine works. At least we know that now. But this lead-in to getting the confirmatory trial set up is painfully slow.

CVM seems to be “slow tracked”. Been here a really long time. Hoping patience pays off. Good luck to everyone. Maybe we are close. But I have been hoping for years. Let’s go already!! Lol.

And some get fast-tracked:
BioAtlas Ozuriftamab Vedotin Receives FDA Fast-Track Designation; Shares Rise
9:38 AM ET 7/23/24 | MT Newswires
BioAtla's Ozuriftamab Vedotin Receives FDA Fast-Track Designation; Shares Rise
09:38 AM EDT, 07/23/2024 (MT Newswires) -- BioAtla (BCAB) said Tuesday that the US Food and Drug Administration has granted fast-track designation to ozuriftamab vedotin, the company's drug candidate to treat patients with squamous cell carcinoma of the head and neck.

The designation applies to drugs that are intended to treat a serious or life-threatening disease or condition, and have demonstrated the potential to address an unmet medical need.

"The FDA's decision is an important recognition of the potential of our CAB-ROR2-ADC, ozuriftamab vedotin," Chief Executive Jay Short said in a statement. "We look forward to discussing with the FDA plans for a potential registrational trial in the second half of this year."

I wouldn't waste your time with him. A glance through his posting history should tell you all you need to know.

A long time trader with experience.

uhhh ok and what is that from?

18 hours ago
It has been shelved along with UK

Cheers!

what makes you say they're shelved indefinitely

Got out at $1.79 LOL The Canadian and UK deals are shelved indefinitely LOL. I finally did the right thing for once.

OK - so now we're up to a float of ~58 Million shares. Still not bad IF they can get the confirmatory study rolling in the next quarter or two.

PROSPECTUS SUPPLEMENT SUMMARY

This summary highlights selected information contained elsewhere or incorporated by reference in this prospectus supplement and the accompanying prospectus. This summary does not contain all the information that you should consider before investing in our securities. You should read the entire prospectus supplement and the accompanying prospectus carefully, including “Risk Factors” contained in this prospectus supplement and the accompanying prospectus, the financial statements incorporated by reference in this prospectus supplement and the accompanying prospectus, and the other documents identified under the headings “Where You Can Find Additional Information” and “Incorporation of Certain Information by Reference” in this prospectus supplement, before making an investment decision.

THE OFFERING

Common Stock we are offering

3,715,000 shares of common stock

Pre-Funded Warrants
We are also offering 7,130,000 Pre-Funded Warrants to purchase up to 7,130,000 shares of our common stock, exercisable at an exercise price of $0.01 per share, to those purchasers whose purchase of common stock in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock immediately following the consummation of this offering. The purchase price of each Pre-Funded Warrant is equal to the price per share of common stock being sold in this offering minus $0.01. The Pre-Funded Warrants will be immediately exercisable and may be exercised at any time until exercised in full. See “Description of Pre-Funded Warrants.” This prospectus supplement also relates to the offering of the shares of common stock issuable upon the exercise of such Pre-Funded Warrants.

Common stock outstanding prior to this offering
54,268,229 shares of common stock.

Common stock to be outstanding after this offering
57,983,229 shares of common stock, assuming no exercise of any Pre-Funded Warrants.

NYSE American Symbol and Listing

Our common stock is listed on the NYSE American under the symbol “CVM.” There is no established public trading market for the Pre-Funded Warrants, and we do not expect a market to develop. We do not intend to list the Pre-Funded Warrants on the NYSE American or any other national securities exchange or nationally recognized trading system. Without an active trading market, the liquidity of the Pre-Funded Warrants will be limited. See “Description of Pre-Funded Warrants.”

Use of Proceeds
We estimate that our net proceeds from this offering will be approximately $9,937,000, after deducting the placement agent fees and estimated offering expenses payable by us, and assuming full exercise of the Pre-Funded Warrants. We intend to use the net proceeds from this offering to fund the continued development of Multikine and for general corporate purposes and working capital. See “Use of Proceeds.”

Risk Factors
Investing in our securities involves significant risks. Please read the information contained in or incorporated by reference under the heading “Risk Factors” beginning on page S-13 of this prospectus supplement, and under similar headings in other documents filed after the date hereof and incorporated by reference into this prospectus supplement and the accompanying prospectus.

The number of shares of common stock shown above to be outstanding after this offering is based on 54,268,229 shares outstanding as of July 26, 2024 and excludes:

16,322,110 shares of our common stock issuable upon the exercise of outstanding stock options at a weighted average exercise price of $6.92 per share; and
1,092,470 shares of our common stock issuable upon the exercise of warrants outstanding at a weighted average exercise price of $3.16 per share.

Except as otherwise indicated, all information in this prospectus supplement assumes (i) no exercise of the outstanding options or warrants described above; and (ii) no exercise of any Pre-Funded Warrants in this offering.

speaking of interesting days, what happened on friday?? lol i was at the fair

58 million shares traded? got up over $2??

CVM under $2

Made for an interesting day - that's for certain. Doesn't really change my long-term position here - but I am guessing it aggravated the H_ll out of a lot of folks who got sucked into the buying rush early in the day when it tanked back down to a realistic trading price again.

$1 mid-day offering.

Good luck to anyone still in.

Hopefully this is one they check mark up hard for all.

My WeBull app says halted

Don't see a trade after 10:45am. Halted? It's 11:00am